BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSEL

    MDR report key: 1881655 · Received September 28, 2010

    Report

    Report Number
    1881655
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 28, 2010
    Manufacturer
    COOK
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A DIAGNOSIS OF LEFT LOWER LEG ISCHEMIA. HE WAS TAKEN TO CARDIAC CATH LAB. A 7FR ANSEL SHEATH INTRODUCER WAS INSERTED INTO LEFT FEMORAL SUPERFICIAL ARTERY WITH THROMBOLYTIC AGENT AND HEPARIN INFUSING. RN EXAMINED THE PATIENT WHO WAS FOUND TO BE PROFUSELY BLEEDING. GROIN PRESSURE INITIALLY HELD, THOUGHT TO BE BLEEDING FROM GROIN AT CATHETER INSERTION SITE. FURTHER EVALUATION PROVED AT THE SITE OF BLEEDING FROM CATHETER AT THE HUB, IT SHEARED AWAY FROM THE CATHETER. SHEATH WAS REMOVED. PATIENT RECEIVED MULTIPLE UNITS OF BLOOD FOR LOW BLOOD PRESSURE AND HEART RATE.====================== MANUFACTURER RESPONSE FOR 7 FR ANSEL SHEATH, (BRAND NOT PROVIDED)======================HAVE NOT HAD A RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANSEL INTRODUCER, CATHETER DYB COOK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR OTHER